Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial.
Gintas P Krisciunas, Kerlly Castellano, Timothy M McCulloch and 11 others
PMID 27848021WHAT IT FOUND
In head and neck cancer patients after radiation, electrical stimulation did not improve swallowing beyond the same stretch and swallow exercise program.
Among the most compliant patients, active stimulation had worse PAS scores than sham, and doing more sessions did not improve outcomes.
Key findings
01Compliance did not differ between active e-stim (57% compliant) and sham e-stim (48% compliant), and both groups received the same stretch and swallow exercise home program.
02Among compliant patients only, active e-stim added to the same stretch and swallow exercise program produced worse PAS scores than sham e-stim, with an adjusted difference of 0.86 points.
03When all patients were pooled, compliant patients did not have better swallowing, diet, or quality of life outcomes than non-compliant patients, regardless of active or sham e-stim.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The compliance analysis was not powered beforehand to compare compliant and non-compliant patients, and the compliant-only analysis used a little more than half of the original sample, so some null results may reflect low statistical power. The compliant threshold was set after the trial and was described by the authors as arbitrary because no accepted dose or compliance target exists for dysphagia rehabilitation. Seventeen of the 170 enrolled patients had no compliance data because they withdrew before starting or were lost to follow-up before outcome measures. The PAS differences were small, and the paper does not settle whether a 0.52 or 0.86 point difference is clinically meaningful. The analysis cannot rule out that swallowing exercises slow decline or help a small subgroup, because it did not directly test those possibilities.
Declared interests
The authors declared no conflict of interest.
The easy way to misread this
Do not conclude that doing more of the home program will improve swallowing, diet, or quality of life. Compliant and non-compliant patients did not have better outcomes on these measures, and among compliant patients the active e-stim group had worse PAS scores than the sham group.